Recognized Consensus Standards: Medical Devices
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Standards
Developing Organization |
Standard Designation Number and Date |
Standard Title (click for recognition information) |
| 06/07/2018 | General Plastic Surgery/ General Hospital |
6-401 | Complete | ASTM | D7160-16 | Standard Practice for Determination of Expiration Dating for Medical Gloves |
| 06/07/2018 | General Plastic Surgery/ General Hospital |
6-270 | Complete | ASTM | F1840-10 (Reapproved 2016) | Standard Terminology for Surgical Suture Needles |
| 08/14/2015 | General Plastic Surgery/ General Hospital |
6-110 | Complete | ASTM | F1441-03 (Reapproved 2014) | Standard Specification for Soft-Tissue Expander Devices |
| 06/07/2018 | General Plastic Surgery/ General Hospital |
6-404 | Complete | ISO | 7886-1 Second edition 2017-05 | Sterile hypodermic syringes for single use - Part 1: Syringes for manual use |
| 06/07/2018 | General Plastic Surgery/ General Hospital |
6-407 | Complete | ASTM | F3186-17 | Standard Specification for Adult Portable Bed Rails and Related Products |
| 08/14/2015 | General Plastic Surgery/ General Hospital |
6-353 | Complete | ASTM | F2051-00 (Reapproved 2014) | Standard Specification for Implantable Saline Filled Breast Prosthesis |
| 12/19/2022 | General Plastic Surgery/ General Hospital |
6-485 | Complete | ISO | 7886-4 Second Edition 2018-11 | Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature |
| 08/14/2015 | General Plastic Surgery/ General Hospital |
6-200 | Complete | ASTM | E1061-01(2022) | Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers |
| 06/07/2018 | General Plastic Surgery/ General Hospital |
6-405 | Complete | IEC | 80601-2-59 Edition 2.0 2017-09 | Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening |
| 06/07/2018 | General Plastic Surgery/ General Hospital |
6-406 | Complete | ASTM | F1862/F1862M-17 | Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) |
| 05/29/2023 | General Plastic Surgery/ General Hospital |
6-494 | Complete | ASTM | F3352/F3352M-23a | Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities |
| 12/20/2021 | General Plastic Surgery/ General Hospital |
6-464 | Complete | ISO | 11040-4 Third edition 2015-04-01 | Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling [Including AMENDMENT 1 (2020)] |
| 08/20/2012 | General Plastic Surgery/ General Hospital |
6-242 | Complete | ISO | 8536-2 Third edition 2010-03-15 | Infusion equipment for medical use - Part 2: Closures for infusion bottles |
| 03/16/2012 | General Plastic Surgery/ General Hospital |
6-269 | Complete | ASTM | F1078-10 (Reapproved 2018) | Standard Terminology for Surgical Scissors-Inserted and Non-Inserted Blades |
| 03/16/2012 | General Plastic Surgery/ General Hospital |
6-271 | Complete | ASTM | F1874-98 (Reapproved 2011) | Standard Test Method for Bend Testing of Needles Used in Surgical Sutures |
| 09/17/2018 | General Plastic Surgery/ General Hospital |
6-123 | Complete | ASTM | E667-98 (Reapproved 2017) | Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers |
| 07/15/2019 | General Plastic Surgery/ General Hospital |
6-423 | Complete | IEC | 60601-2-6 Edition 2.1 2016-04 | CONSOLIDATED VERSION Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment |
| 07/06/2020 | General Plastic Surgery/ General Hospital |
6-441 | Complete | ISO | 7886-3 Second edition 2020-05 | Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization |
| 05/29/2023 | General Plastic Surgery/ General Hospital |
6-493 | Complete | ASTM | F2101-23 | Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus |
| 12/23/2019 | General Plastic Surgery/ General Hospital |
6-427 | Complete | ASTM | F2101-19 | Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus |
| 08/21/2017 | General Plastic Surgery/ General Hospital |
6-384 | Complete | ISO | 1135-4 Sixth edition 2015-12-01 | Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed |
| 08/21/2017 | General Plastic Surgery/ General Hospital |
6-125 | Complete | ASTM | E1965-98 (Reapproved 2016) | Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature |
| 08/21/2017 | General Plastic Surgery/ General Hospital |
6-400 | Complete | ASTM | F3212-16(2023) | Standard Test Method for Coring Testing of Huber Needles |
| 08/21/2017 | General Plastic Surgery/ General Hospital |
6-70 | Complete | ASTM | E825-98 (Reapproved 2016) | Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature |
| 08/21/2017 | General Plastic Surgery/ General Hospital |
6-124 | Complete | ASTM | E1104-98 (Reapproved 2016) | Standard Specification for Clinical Thermometer Probe Covers and Sheaths |
| 01/30/2014 | General Plastic Surgery/ General Hospital |
6-253 | Complete | ISO | 10535 Second edition 2006-12-15 | Hoists for the transfer of disabled persons - Requirements and test methods |
| 05/29/2023 | General Plastic Surgery/ General Hospital |
6-492 | Complete | ASTM | F2100-23 | Standard Specification for Performance of Materials Used in Medical Face Masks |
| 08/06/2013 | General Plastic Surgery/ General Hospital |
6-296 | Complete | ANSI AAMI | PB70:2012 | Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
| 03/18/2009 | General Plastic Surgery/ General Hospital |
6-215 | Complete | ASTM | F2132-01 (Reapproved 2008)e1 | Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps |
| 08/06/2013 | General Plastic Surgery/ General Hospital |
6-240 | Complete | ISO | 8536-3 Third edition 2009-06-01 | Infusion equipment for medical use - Part 3: Aluminum caps for infusion bottles |
| 08/06/2013 | General Plastic Surgery/ General Hospital |
6-276 | Complete | ISO | 8536-1 Fourth edition 2011-09-01 | Infusion equipment for medical use - Part 1: Infusion glass bottles |
| 01/15/2013 | General Plastic Surgery/ General Hospital |
6-122 | Complete | ISO | 8536-5 Second edition 2004-02-01 | Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed |
| 01/30/2014 | General Plastic Surgery/ General Hospital |
6-117 | Complete | ASTM | F2172-02 (Reapproved 2011) | Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers |
| 01/30/2014 | General Plastic Surgery/ General Hospital |
6-303 | Complete | ISO | 10555-5 Second edition 2013-06-15 | Intravascular catheters -- Sterile and single-use catheters -- Part 5: Over-needle peripheral catheters |
| 01/30/2014 | General Plastic Surgery/ General Hospital |
6-305 | Complete | ISO | 10555-3 Second edition 2013-06-15 | Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters |
| 03/16/2012 | General Plastic Surgery/ General Hospital |
6-177 | Complete | ASTM | E1112-00(2018) | Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature |
| 12/20/2021 | General Plastic Surgery/ General Hospital |
6-471 | Complete | USP-NF | M88880_05_01 | Sterile Water for Irrigation |
| 05/29/2023 | General Plastic Surgery/ General Hospital |
6-495 | Complete | ISO | 20698 First Edition 2018-07 | Catheter systems for neuraxial application - Sterile and single-use catheters and accessories |
| 01/30/2014 | General Plastic Surgery/ General Hospital |
6-273 | Complete | ISO | 23908 First edition 2011-06-11 | Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
| 08/06/2013 | General Plastic Surgery/ General Hospital |
6-179 | Complete | ISO | 21649 First edition 2006-06-01 | Needle-free injectors for medical use -- Requirements and test methods |
| 05/29/2023 | General Plastic Surgery/ General Hospital |
6-490 | Complete | ISO | 10555-6 First edition 2015-04-15 [Including AMD1:2019] | Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports [Including AMENDMENT 1 (2019)] |
| 08/14/2015 | General Plastic Surgery/ General Hospital |
6-354 | Complete | ASTM | D7907-14 (Reapproved 2019) | Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves |
| 08/20/2012 | General Plastic Surgery/ General Hospital |
6-278 | Complete | ISO | 11040-5 Third edition 2012-02-15 | Prefilled syringes - Part 5: Plunger stoppers for injectables |
| 12/19/2022 | General Plastic Surgery/ General Hospital |
6-483 | Complete | IEC | 60601-2-35 Edition 2.0 2020-09 | Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use |
| 08/14/2015 | General Plastic Surgery/ General Hospital |
6-185 | Complete | ASTM | F881-94 (Reapproved 2014) | Standard Specification for Silicone Elastomer Facial Implants |
| 09/21/2016 | General Plastic Surgery/ General Hospital |
6-379 | Complete | ISO | 7864 Fourth edition 2016-08-01 | Sterile hypodermic needles for single use - Requirements and test methods |
| 01/30/2014 | General Plastic Surgery/ General Hospital |
6-322 | Complete | ISO | 10555-4 Second edition 2013-06-15 | Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters |
| 01/14/2019 | General Plastic Surgery/ General Hospital |
6-338 | Complete | ASTM | D7866-14 | Standard Specification for Radiation Attenuating Protective Gloves |
| 08/06/2013 | General Plastic Surgery/ General Hospital |
6-295 | Complete | AAMI ANSI | BF7:2012 | Blood transfusion microfilters |
| 03/16/2012 | General Plastic Surgery/ General Hospital |
6-268 | Complete | ASTM | F921-10 (Reapproved 2018) | Standard Terminology Relating to Hemostatic Forceps |
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